Head and neck exercise apparatuses

ABSTRACT

A head and neck exercise apparatus may include a member operatively arranged with a valve mechanism with a threshold pressure. The apparatus may further include an acoustic apparatus, membrane, chromogenic material, or moveable element that may be configured to respond when the pressure within the member is greater in magnitude than the threshold pressure. The head and neck exercise apparatus may also include a member operatively arranged with an acoustic apparatus, membrane, chromogenic material, or moveable element that may be configured, without a valve mechanism, to respond when the absolute pressure within the member is greater in magnitude than a threshold absolute pressure.

BACKGROUND

Sleep disordered breathing, including snoring and obstructive sleepapnea, affects tens of millions of adults in the United States. It isassociated with substantial cardiovascular morbidity and mortality,endocrine disturbances, excessive daytime sleepiness, quality of lifeand performance deficits, and motor vehicle crashes.

Multiple factors contribute to sleep disordered breathing, including theloss of muscle tone that occurs with sleep onset. The breathing passagesof the upper airway, including the nose, oral cavity, and pharynx, aresurrounded by muscles and other soft tissues of the head and neck. Thisloss of muscle tone enables collapse or vibration of these soft tissues,particularly in the oral cavity and pharynx, contributing to sleepdisordered breathing. Treatment of sleep disordered breathing includesapproaches that directly or indirectly enlarge or stabilize thebreathing passages of the upper airway. Treatment options includebehavioral measures such as weight loss, positive airway pressuretherapy, surgery, and oral appliances. All treatments have strengths andweaknesses, whether limited compliance, risks of complications, oroutcomes that can vary widely.

Head and neck exercises have been proposed as an alternative treatmentfor sleep disordered breathing. These isotonic and/or isometricexercises can involve muscles within and surrounding the oral cavityand/or pharynx. A number of the exercises include the generation ofpositive or negative pressure within the oral cavity and/or pharynx.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a head and neck exercise apparatus.

FIG. 1B is a top view of the head and neck exercise apparatus in FIG.1A.

FIG. 1C is a cross-sectional side view of the head and neck exerciseapparatus in FIG. 1A with a closed valve mechanism.

FIG. 1D is a cross-sectional side view of the head and neck exerciseapparatus in FIG. 1A with an open valve mechanism.

FIG. 2A is an exploded view of a head and neck exercise system.

FIG. 2B is a perspective view of the assembled head and neck exercisesystem in FIG. 2A.

FIG. 3A is an exploded view of another head and neck exercise apparatus.

FIG. 3B is a side view of the assembled head and neck exercise apparatusin FIG. 3A.

FIG. 3C is a side view of another assembled head and neck exerciseapparatus, similar to the apparatus of FIG. 3A.

FIG. 4A is an exploded view of another head and neck exercise system.

FIG. 4B is a perspective view of the assembled head and neck exercisesystem in FIG. 4A.

FIG. 5A is an exploded view of another head and neck exercise system.

FIG. 5B is a top view of the assembled head and neck exercise system inFIG. 5A.

FIG. 5C is a cross-sectional side view of the head and neck exercisesystem in FIG. 5A with an open and a closed valve mechanism.

FIG. 6A is an exploded view of another head and neck exercise system.

FIG. 6B is a top view of the assembled head and neck exercise system inFIG. 6A.

FIG. 6C is a cross-sectional side view of the head and neck exercisesystem in FIG. 6A with an open and a closed valve mechanism.

FIG. 7A is an exploded view of another head and neck exercise apparatus.

FIG. 7B is a perspective view of the assembled head and neck exerciseapparatus in FIG. 7A.

FIG. 8A is a perspective view of another head and neck exerciseapparatus.

FIG. 8B is a top view of the assembled head and neck exercise apparatusin FIG. 8A.

FIG. 8C is a cross-sectional side view of the assembled head and neckexercise apparatus in FIG. 8A with a closed valve mechanism.

FIG. 8D is a cross-sectional side view of the assembled head and neckexercise apparatus in FIG. 8A with an open valve mechanism.

FIG. 9A is an exploded view of another head and neck exercise apparatus.

FIG. 9B is a top view of the assembled head and neck exercise apparatusin FIG. 9A.

FIG. 9C is a cross-sectional side view of the assembled head and neckexercise apparatus in FIG. 9A with a closed valve mechanism.

FIG. 9D is a cross-sectional side view of the assembled head and neckexercise apparatus in FIG. 9A with an open valve mechanism.

DETAILED DESCRIPTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention that may be embodied in variousand alternative forms. The figures are not necessarily to scale; somefeatures may be exaggerated or minimized to show details. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a representative basis forteaching one skilled in the art to employ variously the presentinvention.

Referring to all Figures and embodiments described in this application,similarly-numbered parts (e.g., 118, 218, 418, etc.) may have similardescriptions, designs, and embodiments.

Referring to FIGS. 1A, 1B, 1C, and 1D, an embodiment of a head and neckexercise apparatus 110 may be used in the performance of isotonic and/orisometric head and neck exercises for sleep disordered breathing. Theseexercises can include the generation of positive or negative pressurewithin the oral cavity and/or pharynx. These exercises may improve sleepdisordered breathing through a number of mechanisms, including buildingmuscle strength, increasing or coordinating muscle activity, changingsoft tissues characteristics, and improving what may be improperposition of anatomic structures of the head and neck. Analogous totraditional weight lifting and resistance exercises for muscles in otherareas of the body, the use of head and neck exercises apparatuses thatprovide consistent resistance training and feedback could provide anumber of benefits, including facilitating exercise performance andmonitoring.

The head and neck exercise apparatus 110 may include a mouthpiece 112that cooperates with a proximal portion 122 of a member 114. In thisembodiment, the member 114 is cylindrically-shaped and defines apassageway or proximal portion 122 there through. In this embodiment,the member 114 also defines a passageway or distal portion 124 therethrough. A valve mechanism 118 may be operatively arranged with (e.g.,disposed within, connected to, etc.) the member 114. The valve mechanism118 may separate the proximal portion 122 and distal portion 124 when inthe closed position. In certain embodiments, the valve mechanism 118 isbiased towards the closed position (FIG. 1C) unless it is opened (FIG.1D) while the positive pressure in the proximal portion 122 is greaterthan a threshold pressure (e.g., 0.7 pounds per square inch), suchthreshold pressure to be determined by the properties of the member 114(e.g., dimensions, etc.) and/or valve mechanism 118 (e.g., stiffness,thickness, etc.) For example, if the pressure in the proximal portion122 rises above the threshold pressure to open the valve mechanism 118but subsequently falls below the threshold pressure, the valve mechanism118 closes.

The valve mechanism 118 is presented as of the deflection valve type,but other valve mechanism types such as reed valve, leaf valve, duckbillvalve, ball valve, check valve, gate valve, plug valve, and diaphragmvalve, are possible. In other embodiments, the valve mechanism 118 mayopen if the pressure in the proximal portion 122 rises above thethreshold pressure but then remains open if the pressure in the proximalportion 122 subsequently falls below the threshold pressure. The valvemechanism may include some means to return the valve to the closedposition (e.g., reset lever, etc.). In other embodiments, the valvemechanism 118 may be biased towards the open position unless it isclosed when the positive pressure in the proximal portion 122 is greaterthan a threshold pressure, with all other potential configurationsdescribed elsewhere in this application. In other embodiments, the valvemechanism 118 may be biased towards the closed position and open only ifnegative pressure in the proximal portion 122 has an absolute pressuregreater than a threshold negative pressure (i.e., is less than athreshold negative pressure). All other embodiments described forpositive pressure in the proximal portion could be configured fornegative pressure. In this application, an absolute pressure greaterthan a threshold absolute pressure represents a positive pressuregreater than a threshold pressure or a negative pressure less than athreshold negative pressure.

Apparatuses for head and neck exercises for sleep disordered breathingideally provide feedback regarding proper performance of the exercises.As opposed to traditional muscle strength training exercises where grossbody movements enable monitoring of the exercise, a user does not easilyvisualize many head and neck muscles during movement or contraction.Feedback from an apparatus for head and neck exercises for sleepdisordered breathing may indicate correct movements or musclecontractions through a number of means, including those that depend ongeneration of positive or negative pressure within the oral cavityand/or pharynx of a sufficient magnitude or duration.

When the valve mechanism 118 is open, the proximal portion 122 isfluidly connected to the distal portion 124, and airflow may occurbetween the proximal portion 122 and the distal portion 124. Thisairflow (from the proximal portion 122 to distal portion 124 with anopen valve mechanism 118) could provide simple and immediate userfeedback to indicate that there was positive pressure above thethreshold pressure.

User feedback could be based on airflow through an apparatus or anysensory signal (visual, auditory, or tactile). The simplicity of thevalve mechanism 118 avoids the need for a pressure transducer or othermeans that may be complex or expensive, as in many medical apparatusesthat may emphasize precision over simplicity and low cost. Simplicityand low cost are much more important for head and neck exercises forsleep disordered breathing than in most medical applications. Forexample, a user may perform these exercises in a wide range of settingsover a period of time, where inexpensive and easily portable apparatuseswould be favored.

A number of respiratory apparatuses used in medical environments arecapable of monitoring positive or negative pressure, but these may notbe well-suited to the performance of these head and neck exercises forsleep disordered breathing. Respiratory apparatuses are often developedfor disorders affecting the lungs rather than the oral cavity and/orpharynx. This leads to features, such as freely permitting airflowthrough the apparatus (in order to monitor airflow without disturbance),that may be unfavorable for some head and neck exercises for sleepdisordered breathing. These apparatuses or their feedback mechanisms maybe expensive or complex, require electrical parts, or be designed tooffer precision in measurements of pressure or airflow. These featuresmay not be necessary with exercises for sleep disordered breathing.These and other limitations may have prevented the use of respiratoryapparatuses in head and neck exercises for sleep disordered breathingand treatment of many other conditions.

Exercise apparatuses used in other areas of the body (for example,including weights) have been adapted for use in the head and neckregion, but their uses have been limited to strengthening muscles forchewing or teeth clenching that may not be suited to exercises for sleepdisordered breathing. The unique nature of head and neck exercises forsleep disordered breathing requires different apparatus designs.

Three types of apparatuses have been proposed for head and neckexercises for sleep disordered breathing: (1) brushes or apparatuseswith a roughly linear, solid design that can stroke or brush the tongue;(2) tubes designed for drawing liquid from a container connected to apressure transducer; and (3) positive end-expiratory pressure reliefvalves utilizing a coil spring mechanism. There are a number oflimitations of these apparatuses. The first type is not designed forresistance training exercises and does not provide meaningful feedbackregarding many of these exercises. The second is unnecessarily complexand expensive, which may not be favorable for many reasons, includingthose outlined above.

Positive end expiratory pressure relief valves have been proposed forexpiratory muscle training, primarily for disorders affecting the lungssuch as chronic obstructive pulmonary disease. These apparatuses provideresistance training for the chest wall muscles relevant to thesepulmonary disorders, with the threshold pressure level determined with acoil spring mechanism that enables adjustment over a wide (andcontinuous) range. These apparatuses have a number of limitations forthe treatment of sleep disordered breathing. First, they have been usedsolely in expiration, which involves the generation of positive pressurewithin the body only. In addition, the end-expiratory pressure reliefvalve apparatuses have solely relied on airflow (e.g., air flows throughthe apparatus when the expiratory pressure exceeds the thresholdpressure) to provide user feedback.

For some exercises and exercise programs, requiring airflow may not befavorable (airflow can only be maintained for a limited duration,airflow may distract the user from any additional movements that arerequired, etc.). A coil spring mechanism may have technical drawbackscompared to other designs. The wide range of adjustment may bewell-suited to chronic obstructive pulmonary disease in which anexercise program generally consists of a single exercise, but exercisesfor sleep disordered breathing typically involve a number of exercisesin which complexity (e.g., an apparatus with a threshold pressure thatmust be adjusted) may not be favorable. In contrast, a selected range ofsimilar apparatuses with different threshold pressures is morestraightforward and enables the construction of simpler apparatuses.There are other limitations and drawbacks of apparatuses that areavailable currently.

The valve mechanism 118 may have any design that performs the functionsas specified. In other embodiments, the valve mechanism 118 may have ameans of adjustment to alter its properties (e.g., dimensions,resistance to opening, etc.). In other embodiments, the valve mechanism118 may be dependent on either positive or negative pressure. In otherembodiments, the head and neck exercise apparatus 110 may be configuredto allow substitution of the valve mechanism 118. In other embodiments,the member 114 may have no distal portion 124, enabling the proximalportion 122 to communicate directly to the external environment when thevalve mechanism 118 is open.

The mouthpiece 112 may be placed between the lips such that it extendsinside the oral cavity to assist with maintaining the apparatus positionor achieving an airtight communication with the oral cavity. Themouthpiece 112 may be of any configuration or placement (to the lips,between the lips, inside the cheeks, between the teeth, above thetongue, etc.). The mouthpiece 112 may be configured to favor anorientation of at least one structure of the face or oral cavity. Suchan orientation could be desirable in the performance of head and neckexercises for sleep disordered breathing.

The mouthpiece 112 may be separable from the member 114 and may includea coupling element 120 that cooperates with the member 114. In thisembodiment, the coupling element 120 defines a passageway there through.The coupling element 120 and the remainder of the mouthpiece 112 may beseparable. In other embodiments, the mouthpiece 112 may not be separablefrom the member 114 or may be manufactured in continuity with the member114. In other embodiments, any suitable mouthpiece 112 or design of themember 114 may be used as an interface between the user and apparatus. Alocking or snap mechanism may enhance the cooperation between at leasttwo of the mouthpiece 112, coupling element 120, and member 114.

Referring to FIGS. 2A and 2B, an embodiment of a head and neck exercisesystem 210 is shown. The head and neck exercise system 210 may includeat least two members 214, each with a valve mechanism 218, within aproximal housing 226. The proximal housing 226 may interface with adistal housing 227. When assembled, the at least two members 214 andvalve mechanisms 218 may be disposed within a combined housing 228.Other embodiments may include other numbers and/or configuration ofhousings.

In this embodiment, the valve mechanisms 218 are distinct from theproximal housing 226 and distal housing 227, but in other embodimentsany component of the valve mechanism may be manufactured in continuitywith any part of the members 214 or housing. In this embodiment, the atleast two members 214 each define a proximal portion 222 but do notdefine a distal portion. In other embodiments, at least one member 214may define a distal portion.

A mouthpiece 212 may include a coupling element 220 to enable connectionto the proximal portion 222 of the at least two members 214. Connectionof the mouthpiece 212 to the at least two members 214 may allow the userto perform exercises according to the properties of the at least twomembers 214. This configuration could provide a range of thresholdpressures that could be desirable in the performance of head and neckexercises for sleep disordered breathing. An exercise program mayincorporate exercises that require different threshold pressures, and anapparatus with a range of threshold pressures or multiple apparatuseswould reduce the need for adjustment or calibration of any singleapparatus 210 with a single member 214. Adjustment and calibration canintroduce cost, complexity, and expenditure of time and effort, any ofwhich may be undesirable.

In other embodiments, the head and neck exercise apparatus 210 mayinclude at least two mouthpieces 212. In other embodiments, the head andneck exercise apparatus 210 may include a mechanism for substitution ofat least one of the member 214 or valve mechanism 218.

Referring to FIGS. 3A and 3B, another embodiment of a head and neckexercise apparatus 310 is shown. A member 314 may be operativelyarranged with a membrane 330 that may be secured in position with a cap332. The membrane 330 and a cap 332 may be configured to cover agenerally annular open area in the member 314. The membrane 330 may beimpermeable or semi-permeable. Positive or negative pressure in aproximal portion 322 of the member 314 may result in outward or inwardmovement, respectively, of the membrane 330. The pressure required formovement of the membrane 330 or other indication of pressure within theproximal portion 322 of the member 314 may depend on the properties ofthe member 314 or the membrane 330. A mouthpiece 312 may include acoupling element 320 to enable connection to the member 314. Otherembodiments include other methods of securing the membrane 330 to themember 314 such as adhesive, manufacturing as a single unit, etc.Referring to FIG. 3C, another embodiment may include an angled portion334 of the member 314. This may facilitate visualization of the membrane330 by the user. The member may or may not include a valve mechanism(not shown), with all configurations described elsewhere in thisapplication. In other embodiments, the membrane 330 may represent achromogenic material or other means to respond to changes in pressurewithin the member 314 through other means (e.g., color, shape, etc.).

Referring to FIGS. 4A and 4B, another embodiment of a head and neckexercise system 410 is shown. The head and neck exercise system 410 mayinclude a combination of at least two members 414 with or without avalve mechanism 418 and with or without a membrane 430. A mouthpiece 412may include a coupling element 420 to enable connection to the at leasttwo members 414. Each member 414 may contain a proximal portion 422 andmay be of any design (e.g., to perform exercises involving positive ornegative pressure, incorporating other feedback or signaling mechanisms,etc.). The at least two members 414 may be disposed within a proximalhousing 426. This proximal housing 426 may interface with a distalhousing 427. When assembled, the at least two members 414 and valvemechanisms 418 may be disposed within a combined housing 428. Otherembodiments may include other numbers and/or configuration of housings.

In this embodiment, the valve mechanisms 418 are distinct from theproximal housing 426 and distal housing 427, but in other embodimentsany component of the valve mechanism may be manufactured in continuitywith any part of the members 414 or housing. In this embodiment, the atleast two members 414 each define a proximal portion 422 but do notdefine a distal portion. In other embodiments, at least one member 414may define a distal portion.

Referring to FIGS. 5A, 5B, and 5C, another embodiment of a head and neckexercise system 510 is shown. The head and neck exercise apparatus 510may include a combination of at least two members 514, for example atleast two members 514 with a valve mechanism 518; at least one member514 with a valve mechanism 518 and at least one member 514 without avalve mechanism and with a membrane 530; or any configuration describedelsewhere.

A sealing element 534 may be disposed within at least one member 514 tofunction with a spring element 516. The sealing element 534 may separatea proximal portion 522 and a distal portion 524 of the member 514 whenin the closed position (FIG. 5C, right). A spring element 536 (reedspring, leaf spring, compression spring, tension spring, variablespring, etc.) may hold the sealing element 534 biased towards a closedposition (FIG. 5C, right) until the positive pressure in the proximalportion 522 of the member 514 exceeds a threshold pressure level to openthe sealing element 534 and spring element 536 (FIG. 5C, left). Thesealing element 534 and spring element 536 may thus form a valvemechanism, with all other potential configurations described elsewherein this application.

The threshold pressure levels of the members 514 may be differentiatedby at least one characteristic (dimensions, rigidity, etc.) of anyportion of the member 514, including the sealing element 534 or springelement 536. The sealing elements 534 can be fashioned together (shownin the Figures), individually, or in continuity with other parts. Thespring elements 536 can be fashioned together (shown in the Figures),individually, or in continuity with other parts. Other designs thatfunction similarly to a valve mechanism are possible.

In this embodiment, the head and neck exercise system 510 may include asuperior housing 538 that may include at least one of the proximalportion 522 or distal portion 524 of the member 514. An inferior housing539 may also include at least one of the proximal portion 522 or distalportion 524 of the member 514. In this embodiment, the superior housing538 and inferior housing 539 define passageways that are the proximalportion 522 and distal portion 524 of the member 514. Otherconfigurations described elsewhere are possible. The superior housing538 and inferior housing 539 may interface with the use of at least onesecuring element 544 to assemble as a combined housing 540. Otherembodiments may include other numbers and/or configuration of housings.The securing element 544 may be of any form (locking, screw, snap,rivet, etc.).

The distal portion 524 of at least one member 514 may be incommunication with at least one other distal portion 524 of anothermember 514. The head and neck exercise apparatus 510 may include a boss542 that is contoured for a user to place directly against their lips ora portion of their oral cavity. Other embodiments may include the use ofa mouthpiece 512 that may include one or more parts. The boss 542 ormouthpiece 512 may be placed between the lips such that it extendsinside the oral cavity to assist with maintaining the apparatus positionor achieving an airtight communication with the oral cavity. The boss542 or mouthpiece 512 may be of any configuration or placement (to thelips, between the lips, inside the cheeks, between the teeth, above thetongue, etc.). The boss 542 or mouthpiece 512 may be configured to favoran orientation of at least one structure of the face or oral cavity.Such an orientation could be desirable in the performance of head andneck exercises for sleep disordered breathing.

Referring to FIGS. 6A, 6B, and 6C, another embodiment of a head and neckexercise system 610 is shown. The head and neck exercise system 610 mayinclude a combination of at least two members 614 with any configurationdescribed elsewhere. Each member may include a valve mechanism 618configured to be biased towards a closed position (FIG. 6C, right)unless it is opened (FIG. 6C, left) when the positive pressure in theproximal portion 622 exceeds a threshold pressure, such thresholdpressure to be determined by the properties of the member 614 and valvemechanism 618.

The head and neck exercise apparatus 610 may include at least one member614 that does not include the valve mechanism 618. The head and neckexercise system 610 may include at least one member 614 with an openarea that may be covered by a membrane 630. All configurations describedelsewhere are applicable.

The head and neck exercise system 610 may include a superior housing 638that may include at least one of a proximal portion 622 or distalportion 624 of the at least two members 614. An inferior housing 639 mayalso include at least one of a proximal portion 622 or distal portion624 of the at least two members 614. The superior housing 638 andinferior housing 639 may interface to assemble as a combined housing640. The interface between inferior housing 638 and superior housing 639may include at least one securing element 644 (e.g., locking screw,snap, rivet, etc.) that may help to maintain their physicalrelationship. At least one member 614 may include a boss 642 or amouthpiece 612, with all configurations described elsewhere in thisapplication. Other embodiments may include other numbers and/orconfiguration of housings.

Referring to FIGS. 7A and 7B, another embodiment of a head and neckexercise apparatus 710 is shown. The member 714 includes an openproximal portion 722 and may have a sealed distal end. A mouthpiece 712may include a coupling element 720 to enable connection to the proximalportion 722 of the member 714. The head and neck exercise apparatus 710may include a member 714 with at least one air passage opening 746. Theat least one air passage opening 746 may permit airflow freely throughit or may include some resistance to airflow (e.g. resistance valve,semi-permeable material, etc.). Airflow through the at least one airpassage opening 746 may be adjusted with a resistance adjustor 748 thatmay partially or completely occlude the at least one air passage opening746. In this embodiment, the member 714 and resistance adjustor 748 areboth cylindrically-shaped, with the resistance adjustor 748 having alarger diameter in order to enable the resistance adjustor to slide overthe member; other embodiments may include other configurations. Airflowthrough the at least one air passage opening 746 may also be adjusted bymodifying the properties of the at least one air passage opening 746.The resistance adjustor 748 may exist in a sliding relationship and mayinclude a means (e.g., preset locations, etc.) to secure the resistanceadjustor 748 in specific positions (e.g, corresponding to specificchanges in total dimensions of the at least one air passage opening746).

Referring to FIGS. 8A, 8B, 8C, and 8D, another embodiment of a head andneck exercise apparatus 810 is shown. The head and neck exerciseapparatus 810 may include a member 814 that is operatively arranged withan acoustic apparatus 850. A valve mechanism 818 may be disposed withinthe member 814. The valve mechanism 818 may separate a proximal portion822 and distal portion 824 when in the closed position. A mouthpiece 812may include a coupling element 820 to enable connection to the member814.

The acoustic apparatus 850 may be capable of generating an acousticsignal (e.g., whistle, reed, vibrating mechanism, etc.). The acousticapparatus 850 could therefore provide an acoustic signal as feedback tothe user when the valve mechanism 818 is open (FIG. 8D), indicating thatthe positive pressure in the proximal portion 822 has exceeded athreshold pressure. All potential configurations of the valve mechanism818 described elsewhere are possible. The acoustic apparatus 850 couldbe configured to produce acoustic signals with different soundcharacteristics (frequency, amplitude, etc.) that vary according tocharacteristics of the pressure generated by the user within their oralcavity and/or pharynx.

In other embodiments, the member 814 could include the acousticapparatus 850 without a valve mechanism 818. In other embodiments, theacoustic apparatus 850 could be configured to generate an acousticsignal in response to specific positive and/or negative pressures(including configuration with a threshold pressure) within the member814. In other embodiments, the member 814 could incorporate at least oneair passage opening (not shown) and a resistance adjustor (not shown),with all configurations described elsewhere in this application.

Referring to FIGS. 9A, 9B, 9C, and 9D, another embodiment of a head andneck exercise apparatus 910 is shown. The head and neck exerciseapparatus 910 may include a member 914 that is operatively arranged witha moveable element 952. A valve mechanism 918 may be disposed within themember 914. The valve mechanism 918 may separate a proximal portion 922and distal portion 924 when in the closed position. The member 914 andvalve mechanism 918 may have any configuration described elsewhere. Amouthpiece 912 may include a coupling element 920 to enable connectionto the member 914.

The moveable element 952 may be configured such that it may be displacedwhen the valve mechanism 918 is open (FIG. 9D). In the currentembodiment, the member 914 and moveable element 952 are bothcylindrically-shaped, with the moveable element 952 having a largerdiameter, but other configurations are possible (e.g., differentcross-sectional shape, moveable element with smaller diameter, etc.).Displacement of the sliding element 952 may depend on the interactionbetween the sliding element 952 and member 914 (e.g. coefficient offriction, etc.). The moveable element 952 may include at least one stop954 configured to limit the range of movement and reduce the chance ofseparation of the moveable element 952 and the member 914. Visibledisplacement of the moveable element 952 provides a straightforwardmeans of user feedback during performance of a head and neck exercise.In other embodiments, the head and neck apparatus 910 may not include avalve mechanism 918, with the moveable element 952 configured such thatit displaces only if the user generates sufficient positive or negativepressure within the proximal portion 922.

In other embodiments, the member 914 could incorporate at least one airpassage opening (not shown) and a resistance adjustor (not shown), withall configurations described elsewhere in this application.

While embodiments of the invention have been illustrated and described,it is not intended that these embodiments illustrate and describe allpossible forms of the invention. Rather, the words used in thespecification are words of description rather than limitation, and it isunderstood that various changes may be made without departing from thespirit and scope of the invention. Moreover, certain embodiments may beused in head and neck exercises for other conditions or user concernsinvolving muscles and/or other tissues of the head and neck. Otherconditions or user concerns can include disorders of speech orswallowing, skin wrinkles, fat in the head and neck, teeth grinding,facial pain, and mouth breathing.

What is claimed is:
 1. A head and neck exercise apparatus comprising: amember defining an open proximal portion configured to be disposed to auser's mouth; a valve mechanism operatively arranged with the member andbiased towards a closed position unless an absolute pressure in theproximal portion is greater in magnitude than a threshold absolutepressure; and a distal portion including at least one of an acousticapparatus, membrane, chromogenic material, or moveable element eachconfigured to respond to an absolute pressure in the proximal portionbeing greater in magnitude than the threshold absolute pressure, whereinthe proximal and distal portions are fluidly connected when the valvemechanism is not in the closed position.
 2. The apparatus of claim 1wherein the threshold absolute pressure is based on at least one of astiffness of the valve mechanism, a dimension of the valve mechanism, ora dimension of the member.
 3. The apparatus of claim 1 wherein the valvemechanism is configured such that the threshold absolute pressure is notadjustable.
 4. The apparatus of claim 1 wherein the valve mechanism is adeflection valve.
 5. A head and neck exercise apparatus comprising: amember defining an open proximal portion configured to be disposed to auser's mouth; a valve mechanism operatively arranged with the member andbiased towards a closed position unless a pressure in the proximalportion is less than a threshold negative pressure; and a distalportion, wherein the proximal and distal portions are fluidly connectedwhen the valve mechanism is not in the closed position.
 6. The apparatusof claim 5 wherein the valve mechanism is configured such that thethreshold negative pressure is not adjustable.
 7. The apparatus of claim5 wherein the valve mechanism is a deflection valve.
 8. A head and neckexercise apparatus comprising: a member defining an open proximalportion configured to be disposed to a user's mouth; a valve mechanismoperatively arranged with the member and biased towards a closedposition unless a pressure in the proximal portion is greater than athreshold positive pressure that is not adjustable; and a distalportion, wherein the proximal and distal portions are fluidly connectedwhen the valve mechanism is not in the closed position.
 9. A head andneck exercise apparatus comprising: a member defining an open proximalportion configured to be disposed to a user's mouth; a valve mechanismoperatively arranged with the member and biased towards an open positionunless an absolute pressure in the proximal portion is greater inmagnitude than a threshold absolute pressure; and a distal portion,wherein the proximal and distal portions are fluidly connected when thevalve mechanism is in the open position.
 10. The apparatus of claim 9wherein the valve mechanism is configured such that the thresholdabsolute pressure is not adjustable.
 11. The apparatus of claim 9wherein the distal portion includes at least one of an acousticapparatus, membrane, chromogenic material, or moveable element.
 12. Ahead and neck exercise apparatus comprising: a member defining an openproximal portion configured to be disposed to a user's mouth; and atleast one of an acoustic apparatus, membrane, chromogenic material, ormoveable element operatively arranged with the member and configured torespond to an absolute pressure in the proximal portion being greater inmagnitude than a threshold absolute pressure.
 13. The apparatus of claim12 wherein the member further defines at least one air passage opening.14. The apparatus of claim 13 further comprising an adjustment mechanismconfigured to alter an air resistance associated with the at least oneair passage opening or dimensions of the at least one air passageopening.
 15. A head and neck exercise system comprising: (i) at leastone member defining an open proximal portion configured to be disposedto a user's mouth; and (ii) any two or more components selected from thegroup consisting of a first component comprising a first valve mechanismoperatively arranged with the member and biased towards a closedposition unless an absolute pressure in the proximal portion is greaterin magnitude than a threshold absolute pressure, and a first distalportion, wherein the proximal and distal portions are fluidly connectedwhen the valve mechanism is not in the closed position, a secondcomponent comprising a second valve mechanism operatively arranged withthe member and biased towards an open position unless an absolutepressure in the proximal portion is greater in magnitude than athreshold absolute pressure, and a second distal portion, wherein theproximal and distal portions are fluidly connected when the valvemechanism is not in the closed position, and a third componentcomprising at least one of an acoustic apparatus, membrane, chromogenicmaterial, or moveable element operatively arranged with the member andconfigured to respond to an absolute pressure in the proximal portion ofthe member being greater in magnitude than a threshold absolutepressure.
 16. The system of claim 15 wherein the at least two componentsare characterized by different threshold absolute pressures.
 17. Thesystem of claim 15 wherein the two or more components are the same.